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WARNING LETTER

Monroe Grain & Supply, Inc. MARCS-CMS 497806 —

Product:
Animal & Veterinary

Recipient:
Monroe Grain & Supply, Inc.


United States

Issuing Office:
Detroit District Office

United States


   

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
  Detroit District
300 River Place
Suite 5900
Detroit, Ml 48207
Telephone: 313-393-8100
FAX: 313-393-8139 

 

WARNING LETTER
2016-DET-13
 
 
June 29, 2016
 
VIA UPS
                                                                                    
 
David L. Ringger, President and Co-Owner
Randall R. Ringger, Secretary and Co-Owner
Monroe Grain & Supply, Inc.
102 E. Washington Street
Monroe, IN  46772
 
Dear Messrs. Ringger:
 
On January 28 through February 18, 2016, the U.S. Food and Drug Administration (FDA) conducted an investigation of your swine operation located at 102 E. Washington St., Monroe, IN, and (b)(4). This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) that we found during our investigation of your operation. You can find the Act and its associated regulations on the Internet through links on FDA’s web page at www.fda.gov
 
We found that you offered for sale an animal for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. § 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the Act, 21 U.S.C. § 360b. 
 
Specifically, our investigation revealed that on or about August 31, 2015, you sold a hog, identified as line (b)(4) and retain tag (b)(4), for slaughter as food. On or about August 31, 2015, (b)(4) slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of sulfadimethoxine in the hog’s kidney tissue. FDA has not established a tolerance for residues of sulfadimethoxine in swine. The presence of this drug in edible tissue from this animal causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. § 342(a)(2)(C)(ii).
 
The above is not intended to be an all-inclusive list of violations. As a producer of animals offered for use as food, you are responsible for ensuring that your overall operation and the food you distribute is in compliance with the law.
 
You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction. 
 
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
 
Your written response should be sent to Seri Essary, Compliance Officer, U.S. Food and Drug Administration, 300 River Place, Suite 5900, Detroit, MI 48207. If you have any questions about this letter, please contact Compliance Officer Essary at 313-393-8150.
 
 
Sincerely,
/S/ 
Art O. Czabaniuk
District Director
Detroit District Office

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